Label: CVS HEALTH STOMACH RELIEF CHERRY FLAVOR- bismuth subsalicylate tablet, chewable

  • NDC Code(s): 69842-221-12, 69842-221-30
  • Packager: CVS PHARMACY,INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 12, 2023

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  • Active ingredient (in each tablet)

    Bismuth subsalicylate 262 mg

  • Purpose

    Upset stomach reliever and anti-diarrheal

  • Uses

    relieves:

    ▪
    travelers’ diarrhea
    ▪
    diarrhea
    ▪
    upset stomach due to overindulgence in food and drink, including:
    ▪
    heartburn
    ▪
    indigestion
    ▪
    nausea
    ▪
    gas
    ▪
    belching
    ▪
    fullness
  • Warnings

    Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

    Allergy alert: Contains salicylate. Do not take if you are

    ▪
    allergic to salicylates (including aspirin)
    ▪
    taking other salicylate products

    Do not use if you have

    ▪
    an ulcer
    ▪
    a bleeding problem
    ▪
    bloody or black stool

    Ask a doctor before use if you have

    ▪
    fever
    ▪
    mucus in the stool

    Ask a doctor or pharmacist before use if you are taking any drug for

    ▪
    anticoagulation (thinning of the blood)
    ▪
    diabetes
    ▪
    gout
    ▪
    arthritis

    When using this product

    a temporary, but harmless, darkening of the stool and/or tongue may occur.

    Stop use and ask a doctor if
    ▪
    symptoms get worse or last more than 2 days
    ▪
    ringing in the ears or loss of hearing occurs
    ▪
    diarrhea lasts more than 2 days

    If pregnant or breast-feeding, ask a health professional before use.

    Keep Out of Reach of Children

    In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222

  • Directions

    ▪
    chew completely or dissolve tablets in mouth.
    ▪
    adults and children 12 years and older: 2 tablets every 1/2 to 1 hour as needed
    ▪
    do not exceed 8 doses (16 tablets) in 24 hours
    ▪
    use until diarrhea stops but not more than 2 days
    ▪
    children under 12 years: ask a doctor
    ▪
    drink plenty clear fluids to help prevent dehydration caused by diarrhea.
  • Other information

    ▪
    each tablet contains: salicylate 102 mg
    ▪
    store at room temperature
    ▪
    avoid excessive heat
    ▪
    keep this carton for future reference on full labeling

    TAMPER EVIDENT: DO NOT USE IF THE ADHESIVE LABELS AROUND THE BOTTLE CAP IS TORN, BROKEN OR MISSING.

  • Inactive ingredients

    D&C Red No. 27 lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucralose.

    Questions?

    1-866-467-2748

  • Principal Display

    CVS Health™

    NDC# 69842-221-12

    Compare To the active ingredient in Pepto-Bismol® Tablets*

    Cherry Flavor

    Original TWIN PACK

    Stomach relief

    BISMUTH SUBSALICYLATE 262 mg

    Upset stomach reliever/Antidiarrheal

    Soothing relief for 5 symptoms:

    •
    Heartburn
    •
    Indigestion Nausea
    •
    Upset stomach
    •
    Diarrhea

    2-12 COUNT BOTTLES

    24 CHEWABLE TABLETS TOTAL

    Cherry Flavor

    Distributed by:

    CVS Pharmacy, Inc.

    One CVS Drive

    Woonsocket, RI 02895

    © 2016 CVS/pharmacy

    CVS.com 1-800-SHOP CVS

    V-16415

    *This product is not manufactured or distributed by The Procter & Gamble Co., the distributor of Pepto-Bismol®.

    Package Label for 24 Chewable tablets

    CVS Health Cherry Flavor Bismuth Subsalicylate 24 Chewable Tablets

    Package Label for 30 Chewable tablets

    CVS Stomach relief 30 chewable tablets Bismuth Subsaclicylate
  • INGREDIENTS AND APPEARANCE
    CVS HEALTH STOMACH RELIEF  CHERRY FLAVOR
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-221
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE262 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize17mm
    FlavorCHERRYImprint Code RP124
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-221-122 in 1 CARTON03/19/2019
    112 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:69842-221-305 in 1 CARTON08/06/2021
    26 in 1 CELLO PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33503/19/2019
    Labeler - CVS PHARMACY,INC. (062312574)
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